IRB Instructions and FOrms Selection Page

IRB Bulletin 1: Important Changes to the Regulations Governing Human Subject ResearchThe federal regulations governing human subject research are changing effective January
19, 2018. There are some important new requirements that all researchers who work with human
participants need to be aware of and implement in IRB applications submitted AFTER January 19, 2018. To facilitate the implantation of these rules, a series of emails
will be sent to the entire campus. This series of IRB Bulletins will describe the changes that we will have to make to remain in compliance. It is
expected that additional changes will be made after the January 19, 2018 date as more
information and guidance on the regulations are released by the federal HHS Office
for Human Research Protections (OHRP). Some of the changes, such as those relating
to informed consent, can be implemented immediately by researchers should they so
choose. All IRB Bulletins will be archived on the IRB website for future reference. Each IRB Bulletin will include a description of the change and a discussion of the impact of the change
at Southern Connecticut State University as seen by the IRB Chair as of the date of
the bulletin. Please note that the discussion will likely change as more information
and guidance is issued by the OHRP.

REGULATION: All research reviewed by the IRB must conform to the new rules starting
January 19, 2018.DISCUSSION: The new rule, as it is called, will require adjustment for both researchers
and the IRB, and being prepared and educated will make the transition as smooth as
it can be. As we go forward, please note:

There will be changes to the IRB application to reflect what will need to be done,
so researchers should download the application from the IRB website rather than rely on previously downloaded applications when new submissions are created.

The new rules apply ONLY to research submitted AFTER January 19, 2018. All research reviewed and approved BEFORE January 19, 2018 does not need to be "updated" next year to conform to the new regulations,
though it may be at the discretion of the IRB. This will be down on a case-by-case
basis, and in consultation with the researchers.

While the new rules take effect on January 19, 2018, the SCSU IRB process will continue
to adapt and changes as the rules are interpreted by the federal Office for Human
Research Protections (OHRP) and other institutions after that date. The current SCSU
review process, with only minor adjustments, will comply with the new rules, but there
may be some opportunities for simplifying our application and review process as new
information comes to light.